Base jumper or fell runner?

International standards such as ISO 62366, ISO 14971 compliance gurus and journals all talk about taking a risk based approach to elements of your development…

The train at platform 9 and 3/4

We’ve been on a road trip recently, sharing a way of encapsulating the key steps of device development that has been attracting “rave reviews”. I’d…

4 steps to (device) heaven

After I wrote about the MDA’s approach to device development (here’s the post), several people emailed me to find out more. Perhaps, like them, you’re…